HCV Ag Linearity Panel Max

Transcription

1 Linearity Max Catalogue No: LPL-HCVAg-001 The Biomex GmbH HCV Antigen Linearity Max consists of 100 s (Genotypes 1a, 1b, 2b, 2c, 3a) with each containing 1.0 ml of human plasma. This panel spans the upper (97,243 ) and lower limit ( ) of quantification over a wide range, enabling developers to challenge their assays. 1. Intended Use This Linearity (LP) is intended for standard testing by diagnostic manufacturers and researchers during assay development, evaluation, troubleshooting and post-marked surveillance of Hepatitis C core antigen test systems and methods. Moreover, it serves as validation tool to estimate the limit of detection (LOD) and limit of quantification (LOQ) or the identification of cut-off values. 2. Storage and Stability Store the LP at < -20 C to -80 C. Thaw samples at room temperature and mix gently by inversion before usage. Avoid foaming, contamination and repeated freeze and thaw cycles. 3. Warnings and Precautions Infectious material. This product is capable of transmitting infectious diseases. Do not pipette by mouth. 4. Donor Information All panel s have been tested and found negative/non-reactive for anti-hiv 1/2, anti-hcv and HBsAg by C marked tests. Furthermore the s were tested non-reactive for HIV RNA and HBV DNA. 5. Detection Methods ach panel is assayed for with ARCHITCT, anti-hcv with NZYGNOST and COBAS, /Ab with MURX and MO- NOLISA, as well as qualitative testing is performed for the direct detection of HCV RNA with COBAS MPX. Viral load determination is performed with the m2000. Testing is carried out with C marked test. 6. Limitations and Restrictions This panel is for Research Use Only and not intended for human or animal diagnostics, or for therapeutic purposes. ach laboratory has the responsibility to ascertain the suitability of the LP for its particular application and to establish their own guidelines for interpretation of results. Data is provided for informational purposes only. The Biomex GmbH does not claim that others can duplicate these test results exactly. Prevention: P264: Wash hands thoroughly after handling. P270: Do not eat, drink or smoke when using this product P273: Avoid the release to the environment Disposal: P501: Dispose of waste in accordance to applicable local or national regulations. Waste must be disposed in a secured manner. Declaration of used symbols Catalog Number Lot Number Consult Instructions for Use Manufactured by Temperature Limitation Biomex GmbH, straße 38, Heidelberg, GRMANY 01/2017 Page 1 of 6

2 3 1 nzygnost -Ab m Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Biomex GmbH, straße 38, Heidelberg, GRMANY Page 2 of 6

3 3 1 nzygnost -Ab m Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Biomex GmbH, straße 38, Heidelberg, GRMANY Page 3 of 6

4 3 1 nzygnost -Ab m Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Biomex GmbH, straße 38, Heidelberg, GRMANY Page 4 of 6

5 3 1 nzygnost -Ab m Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Biomex GmbH, straße 38, Heidelberg, GRMANY Page 5 of 6

6 Member Assay information: Assay Lot# xp. Date Test Date assay 62999LI Feb-Apr2016 assay 59161LP assay nzygnost Murex /Ab C Ab Ultra assay 5J Biomex GmbH, straße 38, Heidelberg, GRMANY Page 6 of 6